Cleared Special

K123020 - BLIP MODEL BP-700WF

K123020 is an FDA 510(k) clearance for BLIP MODEL BP-700WF, manufactured by Carematix, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 61-day FDA review.

K123020 · Carematix, Inc. · Cardiovascular device
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Nov 2012
Decision
61d
Days
Class 2
Risk

K123020 is an FDA 510(k) clearance for the BLIP MODEL BP-700WF. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Carematix, Inc. (Chicago, US). The FDA issued a Cleared decision on November 28, 2012 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Carematix, Inc. devices

FDA 510(k) Submission Details - K123020

510(k) Number K123020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2012
Decision Date November 28, 2012
Days to Decision 61 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 125d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

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